The document summarizes regulations for the manufacture and sale of Ayurvedic, Siddha, and Unani (ASU) drugs under Schedule Z of the Drugs and Cosmetics Act. It outlines requirements for factory premises including hygienic conditions. It also prohibits the manufacture and sale of certain misbranded, adulterated, or spurious ASU drugs. Penalties are prescribed for contraventions including imprisonment and fines. The central government can prohibit ASU drugs if they pose risks or do not have claimed therapeutic value. Separate licenses are needed if manufacturing occurs at multiple premises.

1. Regulation of manufacture of ASU drugs-
Schedule Z of drugs and Cosmetics Act
for ASU drugs
Dr.U.Srinivasa, D.Pharm, M. Pharm., M.Phil., Ph.D.
Professor and Head, (Dept. of Pharmacognosy)
Srinivas college of pharmacy, Mangalore.
Email. usreenivas1966@rediffmail.com

2. Sections for manufacture and sale of drugs
• Section33(EEC) –
Prohibition of manufacture and sale of certain ASU drugs
• Section33(EED) –
Power of central government to prohibit manufacture, etc.,
of ASU drugs in public interest.
• Section33(F) - Government analysts
• Section33(G) - Inspectors
• Section33(H) - Application of provision of section
22,23,24,25.
• Section33(I) –
Penalty for manufacture, sale, et,. Of ASU drugs in
contravention of this chapter.

3. • Section33(J) - Penalties for subsequent offences
• Section33(K) - Confiscation
• Section33(I) -
Application of provisions to government departments
• Section33(M) - Cognizance of offences
• Section33(N) –
Power of central government to make rules
• Section33(O) - Power to amend first schedule

4. Schedule Z of drugs and Cosmetics Act for ASU
drugs
The Section 33(EEB) of the Drugs and Cosmetics Act
describes the regulations for the manufacture and sale
of ASU drugs.
The Act has set some standards related to the
Hygienic conditions, factory premises, prohibition of
manufacture and sale of certain drugs and penalties for
contravention of this act.
The following requirements are taken into account

5. A. Requirements of Factory premises and
hygienic conditions
1. As per the Act, it is mandatory to maintain proper
hygienic conditions in the factory premises along with
the following requirements.
2. Factory or industry involved in the manufacture of ASU
drugs should not be situated adjacent to open sewage,
drain, public laboratory or any other factory which
produces obnoxious odour, large quantities of waste,
dust or smoke.
3. The premises of manufacturing unit shall be clean,
hygienic and free from insects, rodents and other
contamination.
• NOTE: All the sections fall under the schedule-Z of the
Drugs & Cosmetics Act.

6. 4. The walls and floor of manufacturing rooms should
be smooth, easily cleanable with water and should
not accumulate dust or waste products.
5. The water used in the manufacture shall be pure and
drinking quality. It should be free from pathogenic
organisms.
6. Adequate facility should be provided to process the
containers and closures for washing, cleaning, drying,
etc. and it should be separated from the
manufacturing unit.

7. 7. Suitable arrangement shall be provided for disposing
water and other materials in a manner that it does
not affect the health of people in the surrounding
area.
8. Personnel working in the factory should be free from
contagious diseases.
10. Appropriate dress should be provided to the
workers based on the nature of their work.

8. 11. Adequate facilities for personal cleanliness such as
soap, towel and antiseptics should be provided.
12. Facilities for drinking water, separate wash rooms and
change rooms should be provided for men and women.

9. B. Prohibition of manufacture and sale of certain ASU
drugs
• The Act prescribes some criteria to prohibit the
manufacture and sale of certain ASU drugs which are
not manufactured or sold in accordance of the rules.
• The following categories of ASU drugs can be prohibited
from
• Manufacture and sale.
• Any misbranded, adulterated or spurious ASU drugs.
• Any proprietary or patented medicine which does not
display the list of all ingredients on the label of the
container.

10. B. Prohibition of manufacture and sale of certain ASU
drugs
The selling, stocking and distribution of any ASU drug
which has not been manufactured in contravention of
the provisions of this Act.
The manufacture, sale and distribution of any ASU
drugs for which license has not been issued by the
prescribed authority.
The above rules do not apply to vaidyas and hakims
who prepared ASU drugs for the use of their own
patients.
The above rules do not apply to ASU drugs which are
manufactured in small quantities for the purpose of
examination, test or analysis.

11. C. Power of central government to prohibit the
manufacture, sale & distribution of ASU drugs in Public
interest
The section 33(EED) of the drugs and cosmetics Act
prescribes certain power of the central government
based on which the government can prohibit the
manufacture, sale and distribution of ASU drugs which
involve any risk to humans or animals or such drug
does not have therapeutic value as claimed by the
manufacturer or any misbranded and spurious drugs.
Hence in such circumstance, the government may
prohibit the manufacture, sale & distribution of drugs in
public interest.

12. D. Penalty for the manufacture, sale and distribution of
prohibited ASU drugs
As prescribed under the section 33-1 of the Drugs and
cosmetics Act, any person himself, on his behalf is
engaged in the manufacture, sale and distribution of
prohibited ASU drugs, penalty has been fixed as per
the following guidelines.
Any ASU drug which is deemed to be adulterated or
manufactured without a valid licence shall be
punishable up to one year imprisonment and with fine
up to 2 thousand rupees.

13. D. Penalty for the manufacture, sale and distribution of
prohibited ASU drugs
• Any ASU drug which is deemed to be spurious shall be
punishable with Imprisonment up to 1 to 3 years and
with fine up to 5 thousand rupees.
• Any ASU drug which contravenes any other provision of
the Act shall be punishable with imprisonment up to 3
months and with fine up to 500 rupees

14. E. Manufacture on more than one set of premises
If ASU drugs are manufactured on more than one set
of premises, a separate application shall be made and
a separate license shall be obtained for each
premises.